FDA Law Blog: Biosimilars

NOVEMBER 6, 2023

Admittedly, BiMo inspections (into items like adequacy of bioequivalence data, consistency of clinical trial data with medical records, and compliance with clinical trial protocols) lend themselves better to an RIE than assessing manufacturing compliance with regulatory requirements. We should explain what RIEs are.

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Documentation Medical Records 103

pharmaphorum

SEPTEMBER 16, 2021

The Royal Devon and Exeter NHS Trust has used electronic medical records to document and share medicines decisions with GP practices and community pharmacies. Harnessing technology. Technology can also join up and improve services.

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Biosimilars Community Pharmacies Medical Records Documentation 113

FDA Law Blog: Biosimilars

MAY 13, 2024

This guidance, when finalized, will replace the original version of this document finalized in 2017. There is ample data collected on them during this 24/7 monitoring period such as case notes, contemporaneous patient medical records, and patient tapes. Patients that use ESD undergo continuous 24/7 monitoring.

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Medical Records Documentation 109

Pharmacy Is Right For Me

APRIL 4, 2023

Another unique aspect of this model is that all interprofessional team members can access and document within a universal electronic medical record (EPIC). This has been the case since long before the COVID-19 crisis. This empowers care providers with critical patient information.

Hospitals 130

Hospitals Communication Medical Records Dosage 130

pharmaphorum

OCTOBER 11, 2022

Therefore, to help contextualise study findings, external comparator arms (ECAs) can be employed, which compile data from external sources, such as patient registries and other medical records. However, methodological considerations must be undertaken to ensure the best conduct and minimise potential biases in ECA study designs.

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Documentation Medical Records Dosage Drug Development 98

FADIC

OCTOBER 20, 2023

Medication Therapy  Review (MTR) ■ A list of suggested questions to use when conducting a medication therapy review in a geriatric patient. * What medication are prescribed by any specialists you may see? What medication do you take that do not require a prescription? ■ How to handle missed doses.

Health and Personal Care Stores 52

Health and Personal Care Stores Documentation Medication Therapy Management (MTM) Medical Records 52

Pharmacy Joe

SEPTEMBER 18, 2022

If I’m trying to determine whether venous thromboembolism prophylaxis is appropriate, it is much faster and accurate to see the sequential compression stockings (SCDs) on the patient’s legs than it is to search the medical record for documentation that SCDs were applied.

Medical Records 52

Medical Records Inpatient Documentation Communication 52

Pharmacy Joe

SEPTEMBER 18, 2022

If I’m trying to determine whether venous thromboembolism prophylaxis is appropriate, it is much faster and accurate to see the sequential compression stockings (SCDs) on the patient’s legs than it is to search the medical record for documentation that SCDs were applied.

Medical Records 52

Medical Records Inpatient Documentation Communication 52

pharmaphorum

SEPTEMBER 14, 2022

existing literature, public health, electronic medical records, demographics, etc.) Among survey respondents with high participation interest, 40% cited wanting “people like me” to be represented in trials, with African-American respondents more likely to choose this reason (33% compared to 21% of white U.S. counterparts).

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Vaccines Medical Records Documentation Communication 98

Pharmacy Joe

NOVEMBER 14, 2021

Documentation within the medical record. In 2017 the authors developed and implemented a procedure requiring an opioid status verification by a pharmacist for all fentanyl patch orders. This 3-step procedure includes: 1. Determination of indication 2. Review of prior opioid use 3.

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Hospitals Medical Records Inpatient Documentation 40

RX Note

MARCH 14, 2023

Document the antimicrobial therapy in the patient's medical record or medication chart, including the indication and the intended duration of therapy before further review or cessation. Example of patients with altered pharmacokinetics (e.g. before the availability of culture or susceptibility testing result).

Medical Records 52

Medical Records Hospitals Documentation 52

Amber

AUGUST 11, 2022

Lawyers often need help understanding medical records in preparation for a trial. Medical Transcriptionist Transcribing medical documents is work you can do from anywhere at hours convenient for you. If you’re wanting to sharpen your medical coding skills, then this is a great role to consider.

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Specialty Pharmacies Communication Documentation Medical Records 52

RX Note

JULY 30, 2023

Also, it is important to Document the ADR in the patient's medical record. What other medicines can be used instead? Whether a dose reduction is feasible or practical. The ability to successfully treat the side effect. Educate the patient about the ADR.

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Adverse Reactions Patient Counseling Medical Records Documentation 52

PharmaShots

JUNE 2, 2023

Coding errors will most likely lead to n claim denials and delayed payments if medical necessity is not correctly represented or coding guidelines and best practices were not followed. THYNK assists in patient eligibility & pre-approval checks adding to it medical necessity & documentation checks.

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Insurance Coverage and Processing Health and Personal Care Stores Medical Records Documentation 40

Pharmacy Joe

SEPTEMBER 6, 2021

Don’t get me wrong – I’m not suggesting that you don’t document necessary pieces of information in the medical record, or that you don’t document your interventions.

Hospitals 52

Hospitals Documentation Medical Records Inpatient 52

FDA Law Blog: Biosimilars

OCTOBER 2, 2023

The new guidance is one of three policy documents dedicated to explaining FDA’s interpretation of this statutory authority and their approach to exercising scientific judgment in evaluating drug effectiveness. objective clinical outcomes in the context of detailed medical record collection).

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Drug Development Documentation Labelling Medical Records 62

pharmacy mentor

OCTOBER 22, 2024

PMR system – PMR systems are designed to provide comprehensive and up-to-date medication records for each patient and supports ​​better coordination with other healthcare providers. UPW helps pharmacies adhere to these regulations by automating many of the compliance-related tasks.

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Communication Prescription Management Medication Dispensing Payment Processing 52

Viseven

JULY 26, 2022

Mobile apps can help healthcare workers remember their daily tasks, browse the documentation, and optimize communication within their teams. The mHealth app provides users with the needed medical records regarding their disease, sets up the custom pill reminder, and allows them to keep track of their current health situation.

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Health and Personal Care Stores Dosage Communication Prescription Management 52

Pharmaceutical Technology

JUNE 15, 2023

For example, important information may be locked in knowledge silos or gained through experience, making it difficult to find or document. With the right knowledge solution, not only are experts accessible, their knowledge can be automatically documented and stored for future use.

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Drug Development Compounding Adverse Reactions Dosage 52

HealthPartners

AUGUST 23, 2022

According to the Centers for Disease Control and Prevention (CDC), the fundamentals of MTM include five core elements: Medication therapy review (including assessment of any medication-related problems) An updated personal medication record Development of a medication-related action plan intervention or referral Documentation Follow-up MTM gives patients (..)

Medication Therapy Management (MTM) 40

Medication Therapy Management (MTM) Diabetes Medical Records Hospitals 40

Viseven

JULY 16, 2024

Here are some of the key challenges the industry faces: Fragmented data Health data can live in various databases and spreadsheets and come in different formats, such as text documents, video, and audio files. It outlines how medical data should be used, protected, and disclosed.

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Health and Personal Care Stores HIPAA Pharmaceutical Companies Pharmaceutical Companies 52

The Happy PharmD

OCTOBER 26, 2022

These documents focused on why the sentinel event occurred. In this particular case, the physician folded the medication order when he placed it in the nurse’s bin. The nurse transcribed the medication order on the patient’s (nurse’s) record system. Blaming Employees For Sentinel Events.

Hospitals 52

Hospitals Pharmacy Technician Labelling Medical Records 52

FADIC

OCTOBER 20, 2023

Personal Medication Record (PMR) Patients should be instructed to keep a record of all the medications they are prescribed, whether from the over-the-counter or as prescriptions. If possible, the patient can document the name and personal details of the physician who made the prescription. Pathway/ Protocol 5.

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Health and Personal Care Stores Documentation Medical Records Hospitals 90

Pharmaceutical Technology

JUNE 20, 2023

Using AI in Electronic Medical Record systems AI already plays a significant role in Electronic Medical Records (EMR) which have evolved from being electronic versions of personal health records to providing deep AI-driven analysis that provides clinical decision support (CDS).

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Medical Records Documentation Communication Dosage 52

Pharmaceutical Technology

APRIL 24, 2023

They can analyse data sources such as medical records and even social media content to detect subgroups and geographies that may be relevant to the trial. AI can also alert medical staff and patients to clinical trial opportunities. Optical character recognition (OCR) can address structured and unstructured native documents.

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Documentation Medical Records Communication Drug Development 52